夜尿症女性患者服用DDAVP有效性及安全性：多中心随机双盲安慰剂对照实验
作者：Peter K. Sand, Roger R. Dmochowski, Jyotsna Reddy, Egbert A. van der Meulen 来源：Journal of Urology 日期：2013-02-25
导读
Efficacy and safety of low-dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group study
Abstract
Purpose
Previous studies suggest a lower dose of desmopressin orally disintegrating tablet (ODT) may be effective in females compared to males with nocturia. This study aimed to confirm the efficacy and safety of desmopressin ODT 25 μg compared with placebo in female patients.
Materials and Methods
This 3-month, randomized, double-blind, parallel group study compared once-daily desmopressin 25 μg with placebo in women with nocturia (≥2 nocturnal voids). The co-primary efficacy endpoints were the change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders).
Results
The full analysis set comprised 261 patients (age range 19–87 years). Desmopressin significantly reduced the mean number of nocturnal voids and increased the odds of a ≥33% response compared with placebo during 3 months, assessed by longitudinal analysis (-0.22, p=0.028 and OR 1.85, p=0.006, respectively). Desmopressin increased the mean time to first nocturnal void by 49 minutes compared with placebo at 3 months (p=0.003). The response to desmopressin was seen by Week 1 of treatment and was sustained throughout the trial. Significant increases in health-related quality of life and sleep quality were observed compared with placebo. Desmopressin was well-tolerated. Serum sodium levels remained >125 mmol/L throughout the trial – three transient drops to <130 mmol/L were recorded.
Conclusions
Desmopressin ODT 25 μg is an effective and well-tolerated treatment for women with nocturia. Treatment provides rapid and sustained improvement of nocturia and quality of life.
http://www.jurology.com/article/S0022-5347(13)00310-8/abstract
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